Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020688
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PATANOL OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription AT Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/18/1996 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020688Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/30/2015 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/12/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/17/2003 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20688slr016_patanol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20688slr016ltr.pdf
03/13/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/2001 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/16/2001 SUPPL-13 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020688_S013_PATANOL.pdf
03/20/2000 SUPPL-12 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20688S12LTR.PDF
02/18/2000 SUPPL-11 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020688_S011_PATANOL.pdf
08/17/1999 SUPPL-10 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020688_S010_PATANOL.pdf
09/28/1999 SUPPL-9 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020688_S009_PATANOL.pdf
02/16/1999 SUPPL-8 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020688_S008_PATANOL.pdf
02/05/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-6 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020688_S006_PATANOL.pdf
10/14/1998 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/19/1999 SUPPL-4 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020688_S004_PATANOL.pdf
05/29/1998 SUPPL-3 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020688_S003_PATANOL.pdf
09/04/1998 SUPPL-2 Manufacturing (CMC)-Expiration Date Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020688_S002_PATANOL.pdf
01/15/1998 SUPPL-1 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020688_S001_PATANOL.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/17/2003 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20688slr016_patanol_lbl.pdf

PATANOL

SOLUTION/DROPS;OPHTHALMIC; EQ 0.1% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 204532 AKORN INC
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 209919 ALEMBIC PHARMS LTD
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078350 APOTEX
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 204812 AUROBINDO PHARMA LTD
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 206046 CIPLA
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 209282 FDC LTD
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 209619 GLAND PHARMA LTD
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 204392 MYLAN
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 206306 SOMERSET THERAPS LLC
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 203152 USV
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 200810 WOCKHARDT LTD
PATANOL OLOPATADINE HYDROCHLORIDE EQ 0.1% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 020688 NOVARTIS

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